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Meeting the Need for a Discussion of Unmet Medical Need

As Europe and the world continue to battle against COVID, the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European Union action is now eme...

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Autores principales: Horgan, Denis, Borisch, Bettina, Eliasen, Bogi, Kapitein, Peter, Biankin, Andrew V., Gijssels, Stefan, Zaiac, Michael, Fandel, Marie-Helene, Lal, Jonathan A., Kozaric, Marta, Moss, Barbara, De Maria, Ruggero, Geanta, Marius, Nowak, Frédérique, Montserrat-Moliner, Antoni, Riess, Olaf
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9408346/
https://www.ncbi.nlm.nih.gov/pubmed/36011235
http://dx.doi.org/10.3390/healthcare10081578
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author Horgan, Denis
Borisch, Bettina
Eliasen, Bogi
Kapitein, Peter
Biankin, Andrew V.
Gijssels, Stefan
Zaiac, Michael
Fandel, Marie-Helene
Lal, Jonathan A.
Kozaric, Marta
Moss, Barbara
De Maria, Ruggero
Geanta, Marius
Nowak, Frédérique
Montserrat-Moliner, Antoni
Riess, Olaf
author_facet Horgan, Denis
Borisch, Bettina
Eliasen, Bogi
Kapitein, Peter
Biankin, Andrew V.
Gijssels, Stefan
Zaiac, Michael
Fandel, Marie-Helene
Lal, Jonathan A.
Kozaric, Marta
Moss, Barbara
De Maria, Ruggero
Geanta, Marius
Nowak, Frédérique
Montserrat-Moliner, Antoni
Riess, Olaf
author_sort Horgan, Denis
collection PubMed
description As Europe and the world continue to battle against COVID, the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European Union action is now emerging, and more is proposed, including in relation to tackling “unmet medical need” (UMN). This initiative—directing attention to the future of treating disease and contemplating incentives to stimulate research and development—is welcome in principle. But the current approach being considered by EU officials merits further discussion, because it may prove counter-productive, impeding rather than promoting innovation. This paper aims to feed into these ongoing policy discussions, and rather than presenting research in the classical sense, it discusses the key elements from a multistakeholder perspective. Its central concern is over the risk that the envisaged support will fail to generate valuable new treatments if the legislation is phrased in a rigidly linear manner that does not reflect the serpentine realities of the innovation process, or if the definition placed on unmet medical need is too restrictive. It cautions that such an approach presumes that “unmet need” can be precisely and comprehensively defined in advance on the basis of the past. It cautions that such an approach can reinforce the comfortable delusion that the future is totally predictable—the delusion that left the world as easy prey to COVID. Instead, the paper urges reflection on how the legislation that will shortly enter the pipeline can be phrased so as to allow for the flourishing of a culture capable of rapid adaptation to the unexpected.
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spelling pubmed-94083462022-08-26 Meeting the Need for a Discussion of Unmet Medical Need Horgan, Denis Borisch, Bettina Eliasen, Bogi Kapitein, Peter Biankin, Andrew V. Gijssels, Stefan Zaiac, Michael Fandel, Marie-Helene Lal, Jonathan A. Kozaric, Marta Moss, Barbara De Maria, Ruggero Geanta, Marius Nowak, Frédérique Montserrat-Moliner, Antoni Riess, Olaf Healthcare (Basel) Perspective As Europe and the world continue to battle against COVID, the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European Union action is now emerging, and more is proposed, including in relation to tackling “unmet medical need” (UMN). This initiative—directing attention to the future of treating disease and contemplating incentives to stimulate research and development—is welcome in principle. But the current approach being considered by EU officials merits further discussion, because it may prove counter-productive, impeding rather than promoting innovation. This paper aims to feed into these ongoing policy discussions, and rather than presenting research in the classical sense, it discusses the key elements from a multistakeholder perspective. Its central concern is over the risk that the envisaged support will fail to generate valuable new treatments if the legislation is phrased in a rigidly linear manner that does not reflect the serpentine realities of the innovation process, or if the definition placed on unmet medical need is too restrictive. It cautions that such an approach presumes that “unmet need” can be precisely and comprehensively defined in advance on the basis of the past. It cautions that such an approach can reinforce the comfortable delusion that the future is totally predictable—the delusion that left the world as easy prey to COVID. Instead, the paper urges reflection on how the legislation that will shortly enter the pipeline can be phrased so as to allow for the flourishing of a culture capable of rapid adaptation to the unexpected. MDPI 2022-08-19 /pmc/articles/PMC9408346/ /pubmed/36011235 http://dx.doi.org/10.3390/healthcare10081578 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Perspective
Horgan, Denis
Borisch, Bettina
Eliasen, Bogi
Kapitein, Peter
Biankin, Andrew V.
Gijssels, Stefan
Zaiac, Michael
Fandel, Marie-Helene
Lal, Jonathan A.
Kozaric, Marta
Moss, Barbara
De Maria, Ruggero
Geanta, Marius
Nowak, Frédérique
Montserrat-Moliner, Antoni
Riess, Olaf
Meeting the Need for a Discussion of Unmet Medical Need
title Meeting the Need for a Discussion of Unmet Medical Need
title_full Meeting the Need for a Discussion of Unmet Medical Need
title_fullStr Meeting the Need for a Discussion of Unmet Medical Need
title_full_unstemmed Meeting the Need for a Discussion of Unmet Medical Need
title_short Meeting the Need for a Discussion of Unmet Medical Need
title_sort meeting the need for a discussion of unmet medical need
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9408346/
https://www.ncbi.nlm.nih.gov/pubmed/36011235
http://dx.doi.org/10.3390/healthcare10081578
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